Facts About COVID-19 Vaccines
Facts About COVID-19 Vaccines
Approved and Authorized Vaccines
Below are the vaccines that are approved and authorized in the United States to prevent COVID19:
Vaccine Brand Name
FDA
approval/authorization
status
?
Pfizer-BioNTech/
Cominarity
PfizerBioNTech pediatric covid19 vaccine for children aged 5
-11 [3]
Moderna
Johnson & Johnson/
Janssen
?
Who can get
this
vaccine?[1]
How many shots will
you need?
When are you
fully
vaccinated?
People 12
years and
older
2 shots
Given 3 weeks (21
days) apart [ 2]
2 weeks after
your second
shot
Children
aged 5 ¨C 11
years
2 shots
Given 3 weeks (21
days) apart [ 2]
2 weeks after
your second
shot
Emergency Use
Authorization/ EUA
People 18
years and
older
2 shots
Given 4 weeks (28
days) apart [ 2]
2 weeks after
your second
shot
People 18
years and
older
1 shot
Emergency Use
Authorization/ EUA
2 weeks after
your shot
Full approval for
individuals 16 and
older
Emergency Use
Authorization
(EUA) for
individuals aged
12 ¨C15, and 3rd
booster
Emergency Use
Authorization
(EUA)
1
If you have had a severe allergic reaction (anaphylaxis) or an immediate allergic reaction to any ingredient
in the vaccine you are scheduled to receive, you should not get that vaccine. If you have been instructed
not to get one type of COVID-19 vaccine, you may still be able to get another type. Learn more information
for people with allergies.
2 You should get your second shot as close to the recommended 3-week or 4-week interval as possible.
However, your second shot may be given up to 6 weeks (42 days) after the first dose, if necessary.
3 Children 5 through 11 years old will receive a separate vaccine formulation of the Pfizer-BioNTech COVID19 Vaccine that has one-third the dose given to adolescents and adults.
This document was updated 11/29/2021 using information and guidance available to-date and is subject to change per emerging guidance.
Booster doses: 1
Vaccine brand
name
FDA approval/ authorization
status
Eligible population
When can you get the
booster shot?
You should get a
booster if you are 18
years or older.
Pfizer-BioNTech
6 months after
completion of the
primary 2-dose series.
Emergency Use Authorization/
EUA
You should get a
booster if you are 18
years or older.
Moderna
Johnson &
Johnson/
Janssen
6 months after
completion of the
primary 2-dose series.
Emergency Use Authorization/
EUA
Emergency Use Authorization/
EUA
You should get a
booster if you are 18
years or older.
2 months after
completion of the
single-dose primary
regimen
1
FDA has also authorized the use of heterologous (or ¡°mix and match¡±) booster dose for
currently available (i.e., FDA-authorized or approved) COVID-19 vaccines. COVID-19 vaccines can
be administered as a heterologous (or ¡°mix and match¡±) booster dose in eligible individuals
following completion of primary vaccination with a different available COVID-19 vaccine.
Data Supporting Need for a Booster Shot
Studies show after getting vaccinated against COVID-19, protection against the virus and the
ability to prevent infection with the variants may decrease over time.
Although COVID-19 vaccination remains effective in preventing severe disease, recent data
suggest vaccination becomes less effective over time, especially in people aged 65 and older and
at preventing infection or milder illness with symptoms.
This document was updated 11/29/2021 using information and guidance available to-date and is subject to change per emerging guidance.
The recent emergence of the Omicron variant (B.1.1.529) further emphasizes the importance of
vaccination, boosters, and prevention efforts needed to protect against COVID-19. Early data from
South Africa suggest increased transmissibility of the Omicron variant and the potential for
immune evasion.
Emerging evidence also shows that among healthcare and other frontline workers, vaccine
effectiveness against COVID-19 infection is also decreasing over time.
This lower effectiveness is likely due to the combination of decreasing protection as time passes
since getting vaccinated, as well as the greater infectiousness of the Delta variant.
Data from clinical trials showed that a booster shot increased the immune response in trial
participants who finished a Pfizer-BioNTech or Moderna primary series 6 months earlier or who
received a J&J/Janssen single-dose vaccine 2 months earlier. With an increased immune response,
people should have improved protection against COVID-19, including the Delta variant. For PfizerBioNTech and J&J/Janssen, clinical trials also showed that a booster shot helped prevent COVID-19
with symptoms.
This document was updated 11/29/2021 using information and guidance available to-date and is subject to change per emerging guidance.
COVID-19 Vaccine Dosage and Administration
Vaccine type
Age of
recipient
5 ¨C 11 years
Vial cap color
denoting
formulation
Orange
Concentration
of mRNA/viral
particles per
primary dose
10 ?g (1)
PfizerBioNTech
12 ¨C 17 years
Purple
30 ?g(2)
PfizerBioNTech
Interval
between last
primary to
booster dose
Concentration
of mRNA per
booster dose
Not
recommended
Not applicable
Not
recommended
Not applicable
¡Ý18 years
Purple
30 ?g(2)
¡Ý6 months
30 ?g
¡Ý18 years
Not applicable
100 ?g
¡Ý6 months (3)
50 ?g
¡Ý18 years
Not applicable
5¡Á1010 viral
particles
PfizerBioNTech
Moderna
J&J/ Janssen
(1)
(2)
(3)
¡Ý2 months
5¡Á1010 viral
particles
The Pfizer-BioNTech vaccine for children ages 5 through 11 years has the same active ingredients
as the vaccine given to adults and adolescents. However, children ages 5 through 11 years cannot
get the Pfizer-BioNTech COVID-19 Vaccine given to adults and adolescents. In addition, children
ages 5 through 11 years receive an age-appropriate dose that is one-third of the adult dose of
Pfizer-BioNTech COVID-19 vaccine. Smaller needles, designed specifically for children, are also
used for children ages 5 through 11 years.
Adolescents ages 12 years and older receive the same dosage of Pfizer-BioNTech COVID-19
vaccine as adults.
Booster dose for Moderna is only half the primary dose (50 ?g).
This document was updated 11/29/2021 using information and guidance available to-date and is subject to change per emerging guidance.
What is an Emergency Use Authorization (EUA)?
The United States FDA has made the COVID-19 vaccines available under an emergency access
mechanism called an EUA. The EUA is supported by a Secretary of Health and Human Services
(HHS) declaration that circumstances exist to justify the emergency use of drugs and biological
products during the COVID-19 pandemic.
EUA approved products have not undergone the same type of review as an FDA-approved or
cleared product. FDA may issue an EUA when certain criteria are met, which includes that there
are no adequate, approved, and available alternatives. In addition, the FDA decision is based on
the totality of scientific evidence available showing that the product may be effective to prevent
COVID-19 during the COVID-19 pandemic and that the known and potential benefits of the product
outweigh the known and potential risks of the product. All of these criteria must be met to allow
for the product to be used during the COVID-19 pandemic.
The EUA for COVID-19 vaccines are in effect for the duration of the COVID-19 declaration justifying
emergency use of these products, unless terminated or revoked (after which the products may no
longer be used).
How Can a Vaccine Get FDA Approval?
After the three phases of clinical trials are complete, the vaccine manufacturer must present data to an
FDA review team that proves the vaccine is safe and effective and that its benefits outweigh any risks.
Once a vaccine is approved, it must be properly labeled with its risks and benefits, as well as its correct use,
so health care providers can share this information with their patients.
Before an approved vaccine can get distributed to the public, the manufacturer must test all batches of the
vaccine, called lots, for safety, potency and purity. The FDA reviews this information before the lots can be
released. The FDA also routinely inspects the facilities where the vaccines are produced to ensure the
product¡¯s safety and quality. The Pfizer vaccine has finished and passed this rigorous process.
FACT: COVID-19 vaccines will not give you COVID-19
None of the COVID-19 vaccines currently in development or in use in the United States, containthe live
virus that causes COVID-19. There are several different types of vaccines in development, and the goal for
each of them is to ¡®teach¡¯ our immune systems how to recognizeand fight the virus that causes COVID-19.
Sometimes teaching the immune system can cause symptoms such as fever. These symptoms are normal
and are a sign that the body is building immunity. Learn more about how COVID-19 vaccines work.
It typically takes a few weeks for the body to build immunity after vaccination. That means it is possible a
person could be infected and get sick with the virus that causes COVID-19 just beforeor just after
vaccination. This is because the body has not had enough time to react to the vaccine to provide
protection.
This document was updated 11/29/2021 using information and guidance available to-date and is subject to change per emerging guidance.
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